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eSRA was used in a Japanese research paper on data quality of medical information systems

Japan Society for Medical Informatics

  • 26 August 2021
  • Author: Kenichi Nakano
  • Number of views: 3291
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eSRA was used in a Japanese research paper on data quality of medical information systems

Medical Informatics (Japan Society for Medical Informatics) article on use of eSRA to assess the requirements of the Japan MHLW's "Guideline on security management for medical information systems."

"When should audit trail begin?"

eCF published in Applied Clinical Trials 16-June-2021

"When should audit trail begin?"

Several members of the eClinical Forum's Regulatory Advisory Group have published an article in Applied Clinical Trials on "When should audit trail begin?"  It is a discussion of the regulatory history behind audit trails and its interpretation as it relates to clinical research data originating or residing in EDC or eCOA systems.

We welcome feedback! Please send to: REG@eclinicalforum.org 

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eCF Views & News

eCF Views & News

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Registration for the eCF Asia Autumn workshop is now open!

Registration for the eCF Asia Autumn workshop is now open!

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.

The workshop will be available for in-person participation only. There will be a networking/social event in the evening.  Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here

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Registration for the eCF Asia Autumn workshop is now open!

Registration for the eCF Asia Autumn workshop is now open!

We are happy to announce the topics and registration for the eClinical Forum workshop to be hosted by Kyowa Kirin, in Tokyo Japan on November 13-14, 2025.

The workshop will be available for in-person participation only. There will be a networking/social event in the evening.  Each eCF Member company can use 1 or 2 seats depending on your membership type and as allocated by your eCF Primary Representative. For those wishing to attend a remote eCF workshop, the eCF European workshop in London on Nov 4-6 will have similar topics and will be live-streamed. Click to get more information on the planned topics. Register here

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